(87 days)
The Stryker Navigation System, when used with the SpineMap Go software application, is intended as a planning and intraoperative guidance system to enable open or percutaneous computer assisted surgery. The system is indicated for any medical condition in which computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a rigid anatomical structure such as the pelvis, skull, or spine can be identified. The system assists in the positioning of instruments for procedures on the spine and pelvis, including the following procedures: Screw Placement in the spine and pelvis, Needle Placement in the spine and pelvis.
The Stryker SpineMask™ Tracker is intended to be used as an accessory to the Stryker Spine Navigation Systems. It is placed onto the patient's skin dorsal to the spine. In combination with intraoperative imaging devices, it enables automatic patient registration for open or percutaneous computer assisted surgery. When used for patient tracking, the Stryker SpineMaskTM Tracker supports minimally invasive procedures on the lumbar and thoracic spine.
The Fluoroscopy Adapters and Fluoroscopy Trackers are intended to be used as accessories to the Stryker Navigation System. The Fluoroscopy Tracker is connected to the Fluoroscopy Adapter which is attached to the C-arm fluoroscopy system. The Fluoroscopy Tracker transmits signals that are used by the Stryker Navigation System to calculate the spatial relationship between the C-arm and the patient. The Fluoroscopy Adapter and Fluoroscopy Tracker may be used as part of the Stryker Navigation System, which is indicated for any medical condition in which the use of computer assisted planning and surgery may be appropriate. The system can be used for intraoperative guidance where a reference to a rigid anatomical structure can be identified.
The Stryker Navigation System with the SpineMap Go software application is intended for use as an image guided surgery system to enable open or percutaneous computer assisted spinal surgery. It assists the surgeon in positioning of instrumentation during spinal surgeries. The system provides intraoperative guidance to the surgeon using augmented fluoroscopy. Wireless optical tracking technology is used to estimate the position of navigated surgical instruments and displaying their position on medical fluoroscopic images from mobile C-arm. The Stryker Navigation System with SpineMap Go software is comprised of a platform, SpineMap Go software, navigated instruments (e.g. patient/instrument trackers, pointers), and accessories. The system uses wireless optical tracking technology to display the intraoperative location of navigated surgical instruments relative to mobile C-arm fluoroscopy images. The platform consists of a computer, camera, monitor and IO (input/output) Tablet. The SpineMap Go software is dedicated for spinal procedures as defined in the Indications for Use. Required navigated instruments include instruments such as a patient tracker, an instrument tracker, and pointers. An instrument battery is also required when a battery powered navigated instrument or calibration device is used.
The SpineMap Go software application is a required part of the Stryker Navigation System. It is installed by a Stryker representative on the platform. The SpineMap Go software application is used on a platform and interfaces with Stryker navigated instruments and accessories. It is compatible with the Nav3i Platform family, which includes the NAV3i. NAV3. and NavSuite3. SpineMap Go is an interactive software application that provides the functions necessary to conduct the indicated spinal procedures. The software application implements methods for image adjustment, image registration, and instrument navigation. The SpineMap Go Software Application provides new features including the integration of the SpineMask Tracker and the complete Stryker navigation enabled spine instrument portfolio, an updated Image Acquisition component for 2D C-arm support, support for existing C-arm Fluoroscopy Trackers, an updated user interface for improved usability, an updated software architecture, and improved cybersecurity aspects.
The SpineMask Tracker is a sterile, single use device. It is intended to be used as an accessory to the Stryker Spine Navigation Systems which include the SpineMap 3D and SpineMap Go software applications. It is a flexible, patient tracker that is attached to a patient's skin and provides non-invasive patient tracking of the thoracic and lumbar spine. It is applied to the skin, dorsal to the patient's spine, via an integrated adhesive tape. The SpineMask Tracker includes infrared LED's that are positioned on the flexible portion of the device. The LED positions are measured by the navigation system after the SpineMask Tracker is applied to the patient's back. Upon activation of the SpineMask Tracker, the LED positions are measured (i.e., captured) by the navigation system. While being tracked, the LED positions are measured and compared to their initial positions as determined during the capturing step. The software is able to detect whether the flexible SpineMask Tracker is deformed when the position of the corresponding LED pairs differ significantly. If this difference is beyond a specific threshold, the LEDs are not used for patient tracking.
The Fluoroscopy Trackers and the Fluoroscopy Adapters serve to connect a C-arm with the Stryker navigation system. The Fluoroscopy Adapter is mounted onto the C-arm image intensifier to interface with the Fluoroscopy Tracker. The Fluoroscopy Tracker transmits signals that are received by the navigation camera. The navigation system uses the signals to calculate the spatial relationship between the C-arm and the patient. The position of the C-arm, relative to the patient's anatomy, is displayed on the navigation system monitor. The radiopaque fluoroscopy markers within the Fluoroscopy Phantom on the tracker are used to correct the image distortion caused by the image intensifier sensor technology and to compute the geometry of the C-arm. The computed geometry of the C-arm is defined by the position of the focal point relative to the image sensor. The position of the focal point varies based on the C-arm position and gravity deforming the C-arm. The focal point is used later to compute the correct projection of the 3D tool onto the 2D fluoroscopy image.
The provided text contains information about the Stryker Navigation System with SpineMap Go Software Application, SpineMask Tracker, and Fluoroscopy Trackers and Fluoroscopy Adapters. However, it does not describe a study involving an AI/Machine Learning component with specific acceptance criteria related to accuracy metrics like precision, recall, or F1 score, or human reader performance.
The document primarily focuses on:
- Regulatory Clearance (510(k)): It's a submission for premarket notification, demonstrating substantial equivalence to predicate devices.
- Device Description: Explains the components and how they function for surgical navigation.
- Intended Use: Specifies the medical conditions and procedures for which the devices are indicated.
- Technological Comparison: Compares the subject devices with their predicate devices, particularly highlighting updates to software and adherence to new IEC standards for safety.
- Non-Clinical Testing: Summarizes various engineering and validation tests (intended use/user needs, accuracy, safety, general requirements, software, electrical safety, electromagnetic compatibility).
- Clinical Testing: Explicitly states "No clinical testing was performed."
Therefore, I cannot fulfill most of the requested points as they pertain to AI/ML study design and evaluation metrics which are not present in this document.
However, I can extract the acceptance criteria and reported performance for the system accuracy as described in the non-clinical testing section.
Here's what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance:
| Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| System Accuracy | Mean accuracy of 2 mm point and 2º angular axis displacement within the registration zone. | Positional displacement (mm): Median 0.54, Interquartile Range 0.85, 99th Percentile 2.17, Mean 0.68, Standard Deviation 0.59, 99th Confidence Interval Upper Bound 2.14. |
| Trajectory Angle Displacement (Degrees): Median 0.51, Interquartile Range 0.50, 99th Percentile 2.09, Mean 0.56, Standard Deviation 0.37, 99th Confidence Interval Upper Bound 1.52. | ||
| (95th percentile) | The 95th percentile of the point displacement is ≤3 mm and ≤3° for angular axis displacement. | Implicitly met by reported 99th percentiles (2.17 mm and 2.09 degrees), which are below the 3mm and 3 degree threshold for 95th percentile. |
Note: The reported performance metrics (median, interquartile range, 99th percentile, mean, standard deviation, 99th Confidence interval upper bound) provide more detailed information than just the mean, strongly indicating the device meets the specified accuracy criteria.
The following information CANNOT be extracted or is explicitly stated as N/A from the provided document:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not specified. The "Intended Use/User Needs" testing used "cadaver labs or simulated use tests," but no sample sizes or data provenance are detailed for the accuracy testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable, as this is a navigation system with physical accuracy measurements, not an image interpretation AI/ML device relying on expert ground truth.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable (not an AI/ML image interpretation study).
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The document explicitly states "No clinical testing was performed," and this device does not involve AI assistance for human image readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The accuracy metrics provided are for the system itself, which can be seen as the "standalone" performance in terms of its navigational accuracy. However, this is for a surgical navigation system, not an AI algorithm performing diagnostic tasks.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the system accuracy, the ground truth would be precise, objective measurements from controlled laboratory settings, likely using fiducial markers or calibrated measurement tools. It's an engineering ground truth, not a medical classification ground truth.
- The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set in the conventional sense. The "software" testing mentioned focuses on verification and validation against IEC standards and FDA guidance, not model training.
- How the ground truth for the training set was established: Not applicable.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).